NDC 42747-228

Abstral

Fentanyl

Abstral is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Prostrakan, Inc.. The primary component is Fentanyl Citrate.

Product ID42747-228_d07bb89b-1d6e-43a0-839d-d85a8f0619c5
NDC42747-228
Product TypeHuman Prescription Drug
Proprietary NameAbstral
Generic NameFentanyl
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2011-01-07
Marketing CategoryNDA / NDA
Application NumberNDA022510
Labeler NameProStrakan, Inc.
Substance NameFENTANYL CITRATE
Active Ingredient Strength800 ug/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 42747-228-32

32 TABLET in 1 BLISTER PACK (42747-228-32)
Marketing Start Date2011-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42747-228-32 [42747022832]

Abstral TABLET
Marketing CategoryNDA
Application NumberNDA022510
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-07
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
FENTANYL CITRATE800 ug/1

OpenFDA Data

SPL SET ID:4906457e-30ad-4da7-b3ac-bb9e6651a670
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1053652
  • 1053651
  • 1053658
  • 1053657
  • 1053655
  • 1053654
  • 1053661
  • 1053663
  • 1053660
  • 1053647
  • 1053666
  • 1053664
  • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "Abstral" or generic name "Fentanyl"

    NDCBrand NameGeneric Name
    42747-226AbstralAbstral
    42747-222AbstralAbstral
    42747-224AbstralAbstral
    42747-221AbstralAbstral
    42747-223AbstralAbstral
    42747-228AbstralAbstral
    57881-338AbstralAbstral
    57881-336AbstralAbstral
    57881-332AbstralAbstral
    57881-333AbstralAbstral
    57881-334AbstralAbstral
    57881-331AbstralAbstral
    0378-9119FENTANYLFENTANYL
    0378-9121FENTANYLFENTANYL
    0378-9122FENTANYLFENTANYL
    0378-9123FENTANYLFENTANYL
    0378-9124FENTANYLFENTANYL
    0378-9125FENTANYLFENTANYL
    0378-9126FENTANYLFENTANYL
    0378-9127FENTANYLFENTANYL
    0591-3198FentanylFentanyl
    0591-3212FentanylFentanyl
    0591-3213FentanylFentanyl
    0591-3214FentanylFentanyl
    0781-7240FentanylFentanyl
    0781-7241FentanylFentanyl
    0781-7242FentanylFentanyl
    0781-7243FentanylFentanyl
    0781-7244FentanylFentanyl
    20482-001SUBSYSfentanyl
    20482-002SUBSYSfentanyl

    Trademark Results [Abstral]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ABSTRAL
    ABSTRAL
    77117021 3563010 Live/Registered
    SENTYNL THERAPEUTICS, INC.
    2007-02-27

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